Clinical trial · Observational
Autologous Stem Cell Transplantation for Patients With AL Amyloidosis
NCT04210791CI-TRIAL-00074374enrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study mainly evaluated the efficacy and safety of autologous stem cell transplantation for the treatment of AL amyloidosis, the role of induction and maintenance therapy in autologous stem cell transplantation, and the long-term efficacy and prognosis risk factors of autologous stem cell transplantation for the treatment of AL amyloidosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AL Amyloidosis | AL Amyloidosis | ONTOLOGY_EXACT | 0.98 |
| Plasma Cell Dyscrasia | Plasma Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- overall survival
- timeFrame
- 5 years
- description
- the 5 years overall survival after autologous stem cell transplantation.
- measure
- progression-free survival
- timeFrame
- 5 years
- description
- the 5 years progression-free survival after autologous stem cell transplantation.
- measure
- hematological complete response rate
- timeFrame
- 1 year
- description
- the 1 year hematologic complete response rate after autologous stem cell transplantation.
- measure
- organ response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female; * aged 18-75 years; * Patients with newly diagnosed AL; * Appropriate for autologous hematopoietic stem cell transplantation; * Abnormal M protein or free light chain detected in serum and/or urine * ECOG score 0-2 points; * Subjects (or their legal representatives) must sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study. Exclusion Criteria: * Pregnant and breastfeeding women; * Subjects suffering from multiple myeloma; * hypersensitivity to any treatment drugs; * Subjects have severe cardiovascular disease; * Subjects have a serious physical disease and mental illnesses; * Other conditions that researchers consider are not suitable for transplantation.
References
Publications (1)
- DERIVEDZhang Y, Guo J, Chen W, Zhao L, Huang X. Risk factors, treatments and outcomes of patients with light chain amyloidosis who relapse after autologous stem cell transplantation. Bone Marrow Transplant. 2024 Mar;59(3):350-358. doi: 10.1038/s41409-023-02185-z. Epub 2023 Dec 26. PMID 38148411